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U.S. Department of Health and Human Services

Overview of Direct Order Process for COVID-19 Therapeutics

Important Updates

September 13, 2021: Effective, September 13, 2021, the U.S. Department of Health and Human Services transitioned from a direct ordering process for COVID-19 monoclonal antibody therapeutics (mAbs) to a state/territory-coordinated distribution system. The new system will help ensure consistent availability of COVID-19 mAbs and provide health departments with the flexibility to get these critical drugs where they are needed most. Learn More >>

August 27, 2021 -  FDA and ASPR announce resumption in use and distribution of bamlanivimab/etesevimab in certain states. Learn More »

August 20, 2021 - FDA and ASPR announce the shelf-life extension of bamlanivimab under Emergency Use Authorization for bamlanivimab and etesevimab administered together, extending the shelf life from 12 months to 18 months. Learn More »

June 25, 2021 - Distribution of bamlanivimab/etesevimab paused on a national basis until further notice.
Learn More »

June 15, 2021 - Distribution of bamlanivimab/etesevimab paused to Rhode Island in addition to Arizona, California, Florida, Indiana, Oregon, Washington, Illinois and Massachusetts. Learn More »

May 26, 2021 - Distribution of bamlanivimab/etesevimab paused to Arizona, California, Florida, Indiana, Oregon, and Washington in addition to Illinois and Massachusetts. Learn More »

May 21, 2021 - Distribution of bamlanivimab/etesevimab is paused to Massachusetts in addition to Illinois. Learn More »

May 7, 2021 - Distribution of bamlanivimab/etesevimab is paused to Illinois. Learn More »

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Purpose:

The United States Government (USG) is responsible for the allocation and distribution of monoclonal antibody (mAb) therapeutics for the treatment of COVID-19 as per the Emergency Use Authorizations (EUA) issued by the U.S. Food and Drug Administration (FDA). The USG has developed a process for sites to directly order from the distributor, AmerisourceBergen (ABC).


Ordering Process Overview:

Eligible administration sites must work with their state or territory’s department of health to obtain COVID-19 monoclonal antibody therapeutics.

Required utilization reporting:

  • Weekly reporting on these therapeutics is required every Wednesday through HHS Protect, TeleTracking, or CDC’s National Healthcare Safety Network (NHSN) depending on facility type

  • Instructions are included at the bottom of the ABC order form, and included here for reference

    • To improve availability of treatments for Monoclonal Antibody (mAb) therapies for COVID patients across the nation, the federal government requires entities receiving shipments of mAb treatments to provide weekly reports of mAb treatments administered and stocks on hand through one of the following reporting mechanisms:

      • For Hospitals, mAb therapeutic data reporting is included in the COVID-19 hospital data reporting as described in US Dept. of Health and Human Services FAQ/Guidance.

      • Skilled Nursing Facilities / Long Term Care Facilities are requested to provide data through the CDC’s NHSN data system at a future date (Guidance forthcoming)

      • All Additional Facilities such as Dialysis Centers, Home Health Services, Oncology, and Infusion Centers, are required to provide the requested data through the following portal.

  • First-time users will receive enrollment and reporting instructions in an e-mail from protect-noreply@hhs.gov with the subject line of “Invitation: HHS TeleTracking COVID-19 Portal.” This email provides step-by-step instructions to access the Portal for the first time. If you do not receive an email in the next 48 hours, please contact TeleTracking’s Technical Support at hhs-protect@teletracking.com

  • This page last reviewed: September 15, 2021